Although the Blood Flow Restriction Training (BFRT) system has attracted the attention of health professionals, research on this tool in people with neurological pathology, particularly multiple sclerosis (MS), is very limited. Furthermore, to our knowledge, studies on the effect of the BFRT system on forearm-hand muscle strength and fatigability, coordination and dexterity, functionality and quality of life in people with MS are nonexistent.
The main objective of our study are:
-To know the effects of low intensity training in combination with the BFRT system on upper limb strength and forearm and hand fatigability, dexterity, functionality and quality of life in people with MS.
Secondary Objectives
* To know if a low-intensity muscle strengthening program in combination with the BFRT system is superior to a conventional strengthening program. * To know the adherence and satisfaction with the experimental intervention.
The investigators propose to conduct a randomized controlled trial (RCT) with examiner blinding with pre-intervention, post-intervention and follow-up assessment, following the recommendations of the CONSORT guidelines, designed to study the effects of the application of a low-intensity muscle strengthening program in combination with the BFRT system. This intervention will be carried out at the Leganés Multiple Sclerosis Association (ALEM). Patients will be randomly assigned through the GraphPad Software® QuickCalcs application to 2 study groups. A control group, which will receive a low intensity strengthening program in combination with the BFRT system; and an experimental group, which will receive a high intensity strengthening program.
Voluntary participation will be requested from patients diagnosed with MS in the Leganés Multiple Sclerosis Association (ALEM) who meet the inclusion criteria. Acceptance of the study and signature of the informed consent form will be required prior to the start of the program.
As this is the first study to evaluate the effectiveness and feasibility of a low-intensity muscle strengthening protocol in combination with BFRT on forearm and hand muscle strength and fatigability, coordination, dexterity, functionality and quality of life in people with MS, the sample size will be determined based on the most similar scientific literature possible. Hill et al developed an investigation comparing the adaptations of MS patients to two types of intervention: high intensity or conventional strengthening program versus low intensity in combination with BFRT. Since this is the only investigation to date that includes MMSS exercises in their intervention, we consider that the sample size proposed by Hill et al is the most appropriate for our investigation. The sample size obtained in that investigation was 19 subjects, so for the sample size of the present investigation a total of 19 subjects is proposed. However, estimating a 10% possible percentage of losses, we estimate a total of 21 total participants to be recruited.
Patients will be randomly assigned via the GraphPad Software® QuickCalcs application to 2 study groups. A control group, which will receive a low-intensity strengthening program in combination with the BFRT system; and an experimental group, which will receive a high-intensity strengthening program.
>18 years of age.
Diagnosis of MS according to McDonald criteria (53) with a time of evolution longer than two years.
Assessment on the Kurtzke Multiple Sclerosis Disability Status Scale (EDSS) with a score between 2. 0 (minimal disability in one section of the FS (at least one with a score of 2).) to 7.0 (unable to walk more than a few steps, even with assistance, basically confined to wheelchair and able to transfer from wheelchair to another place, or can manage to go to the toilet for 12 hours a day) .
Stable medical treatment for at least six months prior to surgery.
Diagnosis of a neurological disease or musculoskeletal disorder other than MS.
Diagnosis of a cardiovascular, respiratory or metabolic disease or other conditions that may interfere with this study.
Having suffered an exacerbation or hospitalization in the last 3 months before starting the assessment protocol, or during the therapeutic intervention process.
Having received a course of steroids, intravenous or oral, 6 months prior to the start of the assessment protocol and within the intervention period of the study duration.
Parallel
Muscle strengthening (BFRT)
Other interventionThe experimental group will perform a low-intensity strengthening program (20% 1RM) in combination with the BFRT system consisting of the following exercises: palmar flexion and dorsal flexion; ulnar deviation and radial deviation; pronation and supination; elbow flexion and extension, performing 4 sets of 30/15/15/15 repetitions as usual in this type of interventions. Once the first exercise has been completed, a rest of 3 - 4 minutes should be taken depending on the fatigue perceived by the patient. Subsequently, the other two exercises will be performed following the scheme already outlined. Taking into account the scientific evidence concerning the safety and adverse effects linked to the BFRT system, it is determined that the pressure applied in the experimental protocol will be 60% of the TRP of each subject, following the recommendations that locate the effective pressure between 50 - 80% of the TRP of each subject.
Conventional physical therapy
Other interventionThe control group will perform a conventional muscle strengthening protocol consisting of the following exercises: palmar flexion and dorsal flexion; ulnar deviation and radial deviation; pronation and supination; elbow flexion and extension, with a dumbbell at 70% of 1RM, performing a total of 4 sets of 8 - 12 repetitions each, avoiding muscle failure in each set.
Isometric prehensile hand strength (Kg)
Isometric prehensile hand strength: measured by the JAMAR® fist dynamometer. The JAMAR® dynamometer has been widely cited and is considered the gold standard for the assessment of fist strength. Three measurements of the maximum voluntary maximum isometric contraction (MVC) will be taken with each hand, always starting with the least affected hand; once the three measurements have been taken, the mean of these will be obtained. Major values (Kg) means a higher hand grip strengh (there is not a maximum).
Isometric pincer force (Kg)
Isometric pincer force: a Baseline Pinch Gauge® will be used to assess 3 different types of pinch: terminal opposition grip, in which the anterior and distal face of the first finger contacts the anterior face of the dynamometer, anterior and distal face of the second finger contacts the posterior face of the dynamometer; pulpolateral grip, in which the anterior face of the distal phalanx of the first finger contacts the anterior face of the dynamometer, radial edge of the second finger contacts the posterior face of the dynamometer; tridigital press of the first three fingers, in which the anterior and distal face of the first finger contacts the posterior face of the dynamometer, anterior and distal face of the second and third finger contacts the anterior face of the dynamometer. As in the previous test, 3 measurements will be taken and the average score will be obtained. Major values (Kg) means a better pincer force strengh (there is not a maximum)
Gross coordination for the upper limb (Block and Box; number of cubes)
Box and Block Test (BBT): it will be used to assess coordination and manual dexterity. The patient is seated with the tool, a wooden box divided into two identical halves inside which there are 150 wooden cubes of 2.5 cm of different colors, in front of his midline. The patient has to move as many cubes as possible from one half of the box to the other in 60 seconds. The test is performed first with the dominant hand and then with the non-dominant hand. It is a standardized tool for the measurement of the gross function of the MMSS, having been validated by gender and age in healthy subjects, in turn, it shows a low ceiling and floor effect in people with MS. pincer force A higher number of cubes (there is not a maximun) indicate a better coordination of the upper limb.
Fine coordination for the upper limb (NHPT; time in seconds)
Nine Hole Peg Test (NHPT): this test will be used to assess the function of the MMSS, in particular the fine motor skills of the hand. The tool will be placed in front of the subject's midline, the subject will have to insert the 9 pegs, one at a time, into the 9 holes of a board and then remove them, again one at a time, in the shortest possible time; first with the dominant hand, and then the non-dominant hand, the hand that is not being assessed can hold the board to provide stability. The score is the time in seconds required to insert and remove all the pins. It shows excellent test-retest, inter-rater and inter-rater reliability and adequate internal consistency. Lower time in seconds (s) (not specificated the minimum) in the test indicates a better fine coordination.
Functional status of the upper limb (ABILHAND)
Abilhand: is a self-administered questionnaire to assess the person's manual dexterity, defining this as the ability to perform a series of tasks, regardless of the strategies applied to achieve it. The questionnaire contains 23 items scored from 0 to 2, which correspond to various ADL tasks; the patient will mark the degree of difficulty he or she refers to when performing the activities. The score can range from 0 to 46 points, the higher the score, the better the manual dexterity. Its inter- and intra-rater reliability, internal consistency and construct validity are excellent. A higher score (maximun 46 points) indicates a better functionality.
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